MAUDE Adverse Event Report: KARL STORZ SE & CO. KG N.A.; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	27040GP140-S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was operating during an enucleation of prostate when the loop broke inside of the patient.The broken loop resector was removed from the patient's bladder.A small piece of the instrument was unable to be collected as the surgeon visualized the piece going in to the suction collection.An extensive check of the patient's bladder was completed to ensure there was no injury or retained foreign body.

• Brand Name: N.A.
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; 2151 e grand avenue; el segundo CA 90245
• MDR Report Key: 19310266
• Report Number: 19310266
• Device Sequence Number: 15181277
• Product Code: FAS
• UDI-Device Identifier: 04048551393215
• UDI-Public: (01)04048551393215(240)27040GP140-S(17)280317(10)37CC8175
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/22/2024
• Report Date (Section F): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27040GP140-S
• Device Catalogue Number: 27040GP140-S
• Device Lot Number: 37CC8175
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Date Report Sent to FDA: 03/22/2024